private label azelaic acid serum manufacturer low moq

What azelaic acid concentration is legal in an OTC cosmetic serum in the US?

By Blake Mereby · Last reviewed July 24, 2026

There is no hard cap for cosmetic use, but most US private label brands formulate at 5–10% to remain clearly in cosmetic territory. Concentrations above 15% with specific disease claims (acne, rosacea treatment) risk FDA classification as an unapproved drug. Your cosmetic chemist should review all label claims before finalization.

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